Kornimate/medical-research-clean huggingface dataset:
in hepatitis c patients treated with interferon and ribavirin, does hepcidin contribute to treatment induced anaemia

Conditions: Hepatitis C

Summary: the standard treatment of chronic hepatitis c infection is pegylated interferon alpha combined with ribavirin. anaemia is a common complication occurring in up to 30% of subjects. unfortunately, side effects of interferon and ribavirin therapy can require dose reductions, reducing the likelihood of sustained viral response. recent data shows that interferon alpha may increase hepcidin (a key iron regulator) production, resulting in impaired iron availability for production of red blood cells. in this study, we will evaluate hepcidin levels in 30 patients with hepatitis c who are treated with interferon containing regimes. if hepcidin plays a role in interferon-induced anaemia, cheap and readily available oral hepcidin inhibitors could be trialled to potentially reduce the impact of interferon alpha induced anaemia.


Eligibility criteria:
inclusion criteria: * any patient with hepatitis c eligible for treatment with pegylated interferon alpha containing regimes. exclusion criteria: * less than 18 years of age

Keywords: hepatitis c interferon ribavirin hepcidin iron metabolism
evaluation of regional ventilation distribution in patients affected by abdominal sepsis after emergent laparotomy

Conditions: Abdominal Sepsis; Acute Respiratory Failure; Ventilation Therapy; Complications; Emergencies

Summary: the goal of this clinical trial is to evaluate regional ventilation distribution in patients admitted to the intensive care unit after emergent laparotomy due to abdominal sepsis. the main question it aims to answer is: • evaluate if patients admitted after an open abdomen strategy have a different regional ventilation distribution compared to patients in which abdomen is closed at the end of the procedure participants will undergo non-invasive monitoring (esophageal pressure and electrical impedance tomography) and an blood gas analysis samples. researchers will compare open abdomen group and closed abdomen group to see if the ventilation distribution pattern is different.


Eligibility criteria:
inclusion criteria: * age \> 18 and \< 90 years * admitted to the icu after emergent laparotomy for abdominal sepsis * acute respiratory failure exclusion criteria: * controindications to electrical impedance tomography monitoring * body mass index \> 40 kg/m2 * haemodinamic instability * pneumothorax - pneumomediastinum * refusal to participate

Keywords: electrical impedance tomography emergent laparotomy compliance partinioning
place of intrathecal cxcl-13 in the diagnosis of lyme neuroborreliosis

Conditions: Lyme Borreliosis

Summary: neuroborreliosis (nbl) is diagnosed in 10-15% of patients with lyme borreliosis. in europe in adults, the main clinical manifestation is called "bannwarth syndrome". this includes painful meningoradiculitis, sometimes accompanied by cranial nerve neuritis. current european guidelines issued by the european federation of neurological societies (efns) recommend the following triad for the diagnosis of "definite nbl": (i) neurological symptoms suggestive of nbl without any other obvious cause; (ii) csf pleocytosis; (iii) intrathecal production of specific anti-borreliella antibodies. cxcl13, c-x-c chemokine motif ligand 13, is a chemokine implicated in b cell chemotaxis. extensive literature exists on the analysis of cxcl13i as a diagnostic marker for acute nbl. a recent meta-analysis from 2018, published by rupprecht et al finds an overall sensitivity and specificity of 89% and 96% respectively, indicating satisfactory diagnostic value. in this study, the investigators wish to assess the place of this new marker in the diagnosis of neuroborreliosis before proposing it as a test carried out by the borrelia cnr.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject having consulted at the hus between 01/01/2013 and 31/12/2018 * subject not having, after being informed, expressed their opposition to the reuse of their data for the purposes of this research exclusion criteria: * subject who expressed their opposition to participating in the study * subject under guardianship or curatorship * subject under safeguard of justice

Keywords: lyme borreliosis lyme neuroborreliosis bannwarth syndrome intrathecal cxcl-13
cohorte coscinus - biocollection

Conditions: Spinal Cord Injury

Summary: coscinus is a standardized framework for evaluating temporal trends in sci causes, sci characteristics, and demographic patterns. it allows a precise estimation of medical complications' incidence, their evolution over time, as well risk factors influencing these complications, including management modalities. moreover, coscinus provides a high-quality research platform, including clinical, epidemiological, biostatistical, and it expertise, thereby promoting fundamental research in spinal cord injury and related autonomic dysfunctions. as a national epidemiological tool, coscinus offers unique analytical perspectives, promising significant contributions to the understanding and management of spinal cord injuries.

the neurological physical and rehabilitation medicine (nprm) department at nantes university hospital, referral centre for sci patients, has been working since 2015 on the creation of a comprehensive database. this database systematically collects a wide range of data, including socio-demographic, clinical, health status, activity and participation data for sci patients. paired with this database is a longitudinal biocollection that preserves blood, urinary, and feces samples enabling analyses of the microbiome, biomarkers as metabolic, inflammatory, immune, and injury severity biomarkers. the coscinus cohort and its biocollection, created through a multidisciplinary approach, are longitudinally structured. they entail meticulous and continuous recording of standardized data and specific sample collection across various phases of spinal cord injury management, from the acute phase through long-term follow-up. data and samples are collected prospectively at specific time points: acute phase, admission to prm department, 6 months post-injury, discharge and during scheduled follow-up consultations (1 / 2 / 3 years post-injury...) with additional collection in case of complications

Eligibility criteria:
inclusion criteria: * all individuals with spinal cord injury admitted to the neurological prm department of the nantes university hospital at the initial phase of development of the paraplegia or tetraplegia could participate, regardless the clinical neurological status. exclusion criteria: * patients not covered by social security.
a study to evaluate 608 in patients with ankylosing spondylitis (as)

Conditions: Ankylosing Spondylitis

Summary: this study will evaluate the effect and safety of 608 in patients with as.

the purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo and positive drug in patients with as.

Eligibility criteria:
inclusion criteria: 1. female and male patients at least 18 years of age at the time of screening. 2. participant with a clinical diagnosis of ankylosing spondylitis (as) and meeting the modified new york criteria for as. 3. bath ankylosing spondylitis disease activity index (basdai) score \>= 4 and a patient's assessment of total back pain score \>= 4 based on a 0 - 10 numeric rating scale (nrs) at the screening and baseline visits. 4. if entering the study on concomitant nsaids for as, participant must be on stable dose(s) for at least 2 weeks prior to the baseline visit. exclusion criteria: 1. patients with other uncontrolled active inflammatory diseases. 2. clinical laboratory tests and other tests that reveal abnormalities with clinical significance 3. patients who have active hepatitis b, hepatitis c or hiv infections as determined by positive results at screening. 4. history of cancer. 5. known or suspected history of immunosuppression.
does caffeine reduce rosuvastatin-induced protection against ischemia-reperfusion injury?

Conditions: Ischemia Reperfusion Injury

Summary: does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?

rosuvastatin is a proven cholesterol lowering medicine, which hereby is assumed to achieve a reduction in cardiovascular events. apart from it's cholesterol lowering action, rosuvastatin may also increase tolerance against ischemia-reperfusion injury. in dogs rosuvastatin increases the endogenous concentration of adenosine, by enhancing the activity of the enzyme ecto-5'-nucleotidase, which converts adenosine monophosphate into adenosine. we hypothesize that rosuvastatin increases tolerance against ischemia-reperfusion injury by induction of ecto-5'-nucleotidase and thereby increasing adenosine activity. this protective effect of rosuvastatin can be abrogated by using the adenosine receptor antagonist caffeine.

Eligibility criteria:
inclusion criteria: * male * age between 18-50 yrs * signed informed consent exclusion criteria: * cardiovascular disease * hypertension (systole \> 140 mmhg, diastole \> 90 mmhg) * hypercholesterolemia (fasting total cholesterol \> 6,0 mmol/l) * drug abuse * concomitant medication use * inability to perform the ischemic isometric muscle contraction * diabetes mellitus (fasting glucose \> 7.0 mmol/l or random glucose \> 11.0 mmol/l) * alanine-amino-transferase (alat) \>90u/l (more than twice the upper level of the normal range) * creatinine kinase (ck) \>340u/l (more than twice the upper level of the normal range) * participation in any trial concerning medicinal products during the last 60 days prior to this study. * participation in clinical trial involving

Keywords: rosuvastatin caffeine ischemia reperfusion
examination of the metabolic effects of direct bile salt delivery to the ileum in humans

Conditions: Glucose Intolerance; Gastric Bypass Surgery

Summary: this project will evaluate distal intestinal bile salt administration in humans by deliving ursodeoxycholic acid (udca) into the terminal ileum of subjects with a pre-existing ileostomy and assessing several hormone levels following an oral glucose tolerance test compared to a placebo.

ursodeoxycholic acid (udca) is currently fda-approved for the treatment of gallstone dissolution and primary biliary cirrhosis. other than these two diseases, exploratory research - both preclinical and clinical - has demonstrated other beneficial effects of udca. for example, systemic administration of udca for several weeks (4-6 weeks) has been shown to improve insulin sensitivity in non-diabetic, obese individuals. whether or not these effects on insulin sensitivity may be acute in nature and are detectable by ogtt are unknown. based on growing knowledge of bile salt receptors in the gastrointestinal tract, at least some of these effects of bile salts on metabolism appear to be mediated by receptors constitutively expressed in the terminal ileum (e.g. tgr5 receptor that is upstream of glp-1 and insulin secretion that control blood glucose levels). thus, metabolic effects may be inducible with acute udca administration directly into this region of the intestine that could be useful in screening compounds or designing future mechanistic studies. this pilot study is designed to examine the effects of udca on oral glucose tolerance versus a placebo in non-diabetic across a range of body mass indexes by infusing udca directly into the ileum of volunteering subjects with a pre-existing ileostomy and measuring hormone response. the investigators aim to recruit approximately 4-5 volunteers in a lean bmi range (18.5-25 kg/m2), overweight (\>25-29.9), class 1 obesity (\>30-35 kg/m2), and class 2 obesity (\>35-40 kg/m2) for a total of \~16-20 participants.

Eligibility criteria:
inclusion criteria: * able to give informed consent * presence of an ileostomy \> 2 months * weight stable\* for \>2 months (i.e. no greater than 7% change in body weight the last 2 months) exclusion criteria: * crohn's disease * steroid use in the last 3 months * documented/known diagnosis of type 1 diabetes or type 2 diabetes, chronic liver disease, chronic kidney disease, heart failure, cardiac dysrhythmias, or familial hypercholesterolemia * current use of any over-the-counter or prescription oral bile salt * currently pregnant * current use of medications that are known to interact with ursodiol * current or former smoker within the last year.

Keywords: glucose ileostomy
visual mismatch negativity in attention bias modifcation treatment for anxiety

Conditions: Social Anxiety Disorder; Generalized Anxiety Disorder

Summary: this study examines the emergence of the visual mismatch negativity (vmmn) erp component in response to deviations from the embedded contingency in attention bias modification treatment (abmt) for social and generalized anxiety, and the interaction between vmmn emergence and clinical improvement. \*\*\*as of september 2017, recruitment of sad participants has concluded.

all participants, suffering from either social anxiety disorder or generalized anxiety disorder, will receive 6 sessions of abmt, adapted for an oddball paradigm. two of the sessions will also include simultaneous eeg measurement. the goal of the study is to determine the emergence of vmmn in response to trials deviating the embedded contingency and to examine the correlation between vmmn emergence and clinical improvement of anxiety symptoms.

Eligibility criteria:
inclusion criteria: * a signed consent form * men and women between the ages of 18 and 65. * meeting a current diagnosis of social anxiety disorder (sp) or generalized anxiety disorder according to the dsm-iv * sp/gad as the primary diagnosis: in cases of co-morbidity, sp/gad will be deemed as the most distressing and clinically significant condition among the co-morbid disorders. * stable pharmaco-therapy: participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure. exclusion criteria: * a diagnosis of psychotic or bipolar disorders. * a diagnosis of a neurological disorder (i.e., epilepsy, brain injury). * drug or alcohol abuse. * a pharmacological treatment that is not stabilized in the past 3 months. * another psychotherapeutic treatment. * change in treatment during the study. * poor judgment capacity (i.e., children under 18 and special populations).

Keywords: abmt social anxiety generalized anxiety
evaluating the effectiveness of a new way of organizing primary health care to improve the management of alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the objective of the present study is to evaluate the effectiveness of a general practitioner (mg) management strategy guided by a multidimensional evaluation on the multidimensional score of fragility of patients with mild to moderately severe dementia, compared to those currently implemented (without the provision of such an assessment). the measurement of the respective effectiveness of the two types of care in primary care will itself be based on a multidimensional evaluation performed independently in the memory center having established the diagnosis of alzheimer's disease. the secondary objectives are the evaluation of the impact of the strategy on the functional abilities of patients, the incidence of geriatric syndromes, cognitive functions, quality of life of the patient and the burden of the primary caregiver. the efficiency of the strategy will be assessed through a cost-effectiveness analysis. a survey of opinions will also be conducted among primary health care providers, carers and cms on the implemented system.


Eligibility criteria:
inclusion criteria: * patients with probable alzheimer's disease, according to the criteria usually used in memory centers * aged over 64 years with mild to moderately severe dementia syndrome * volunteers for medical follow-up for a period of 20 months; which the general practitioner attending agrees to participate in the research exclusion criteria: * patients under 65 years old * presenting with early cognitive decline or severe dementia * not meeting the clinical diagnostic criteria for alzheimer's disease * refusing or unable to sign informed consent to participate * not voluntary for medical follow-up for a period of 20 months * whose general practitioner refuses to participate in the research
phase 1 study of mdx-1401 in patients with cd30-positive refractory/relapsed hodgkin's lymphoma

Conditions: Hodgkin's Lymphomas

Summary: to establish the safety and tolerability profile of mdx-1401 in patients with relapsed or refractory hodgkin's lymphoma (hl).


Eligibility criteria:
inclusion criteria: * diagnosis of cd30-positive hl by immunohistochemistry or flow cytometry * must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant * bi-measurable disease * ecog performance status of 0 - 2 * meet all screening laboratory values exclusion criteria: * previous treatment with any other anti-cd30 antibody * history of allogeneic transplant * any tumor lesion greater than or equal to 10 cm in diameter * any active or chronic significant infection * underlying medical condition which will make the administration of mdx- 1401 hazardous * concomitant corticosteroids, chemotherapy, investigational agents, other anti-hl biologics, or radiation therapy

Keywords: hodgkin's cancer bi-measurable disease lymphoma
comparison of two strategies for surfactant prophylaxis in premature infants

Conditions: Premature Birth; Premature Lungs

Summary: the purpose of this study is to determine whether the immediate bolus strategy combined with early nasal cpap (ncpap) treatment could decrease the subsequent need for ventilation compared to the administration of surfactant prophylaxis at 15 minutes after birth with early ncpap in premature infants.

respiratory distress syndrome (rds) is a syndrome in premature infants caused by developmental insufficiency of surfactant production and structural immaturity in the lungs. exogenous surfactant therapy has become well established in newborn infants with rds. surfactant replacement therapy, either as a rescue treatment or a prophylactic, reduces mortality and several aspects of morbidity in babies with rds. it is known that infants who are at a significant risk of rds should receive prophylactic surfactant therapy, but the optimal timing and strategy for prophylactic surfactant therapy remains controversial. when administered immediately after delivery, surfactant mixes with the fetal lung fluid and reaches the alveoli before the onset of lung injury potentially created by the first applied positive pressure ventilation. as another approach, surfactant prophylaxis may be administered after resuscitation and stabilization.

Eligibility criteria:
inclusion criteria: * premature infants born before 28 weeks' gestation * premature infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery exclusion criteria: * infants died at delivery room

Keywords: prophylactic surfactant premature mechanical ventilation mortality morbidities
effect of a higher than maximum 450iu gonadotropin dose in an in-vitro fertilization cycle

Conditions: Subfertility

Summary: this goal of this study is to evaluate the outcomes from in vitro fertilization cycles where a 450 iu daily dose of gonadotropins is administered compared to those where a 600 iu daily dose is administered for women who are at risk of a poor ovarian response in order to determine if one dose or the other results in improved cycle outcomes.


Eligibility criteria:
inclusion criteria: * resident of canada * premenopausal * age 40 years or less at the time of enrollment * at risk of a poor ovarian response defined as: either \ 10 iu/l, amh \< 1 pg/ml , antral follicle count less or equal to 8 or previous ivf cancellation * primary infertility or secondary * not previously undertaken a cycle that was included in this study exclusion criteria: * simultaneous participation in another clinical trial * body mass index (bmi) \> 38 kg/m2 * early follicular phase (day 2-4) serum fsh level \> 20 miu/ml * any contraindication to being pregnant and carrying a pregnancy to term * contraindication for the use of estrace® , suprefact®, menopur®, bravelle®, hcg, and luteal phase support medication * any ovarian or abdominal abnormality that may interfere with adequate transvaginal ultrasound evaluation * administration of any investigational drugs within three months prior to study enrollment * patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study * positive results of screening of either partner for hiv antibodies, hepatitis b (other than for surface antibodies present after vaccination) or hepatitis c * unwillingness to give written informed consent

Keywords: ivf dose comparison of gonadotrophins poor responder to ovarian stimulation
adolescent projections during transition in prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: single-center, cross-sectional qualitative study seeking to collect the experience of adolescence and the transition to adulthood of people affected by prader-willi syndrome in a population. to do this, the present will carry out a qualitative study with a reflexive thematic analysis of the data collected through semi-structured interviews using an interview guide.


Eligibility criteria:
inclusion criteria: * patients with genetically confirmed prader-willi syndrome * patients affiliated or beneficiaries of a social security system * patients known and followed by the reference center, presenting sufficient intellectual skills to answer the interview questions exclusion criteria: * refusal of family participation (if minor) * refusal of participation by the patient or his guardian (if of legal age)
neck-trunk stabilization exercises and bobath therapy spastic diplegic cerebral palsy

Conditions: Cerebral Palsy Spastic Diplegia

Summary: physiotherapy is widely used in the treatment of children with cerebral palsy. this study is conducted to identify the most appropriate physiotherapy approach. the purpose of the study is to compare two physical rehabilitation strategies i.e., neck-trunk stabilization exercises and bobath therapy, to investigate their effectiveness on trunk control and upper limb function. the aims of treatment are to influence muscle tone and improve postural alignment by specific handling technique.

the study will be a randomized clinical trial conducted at the physiotherapy outpatient clinic of the tertiary care hospital in sialkot, idrees hospital. following the approval of the basr, the study will be completed within six months. the sample will be taken using a non-probability convenient sampling technique, and the sample will be randomly divided into two groups. a sample size of 44 patients will be taken in this study. there will be two groups. both groups will receive conventional therapy consisting of stretching, strengthening, range-of-motion exercises, positioning, and electrical stimulation. group a: this group will receive neck-trunk stabilization exercises. group b: this group will receive bobath therapy. the total intervention protocol will be given for six weeks' duration, with three sessions per week of about 45 minutes each. outcome measures tools will be segmental assessment of trunk control (satco) and manual ability classification system (macs). children with spastic diplegic cerebral palsy will be measured at baseline and after 6 weeks.

Eligibility criteria:
inclusion criteria: * children diagnosed with spastic diplegic cerebral palsy * children with score of gmfcs \[2\] \[3\] \[4\] levels(2, 16). * signed consent form from parents/guardians. exclusion criteria: * children with visual impairments * children with major auditory impairments * children with previous orthopedic surgery and botulium toxin-a injection at least for 6 months * children having pharmacological intervention for the inhibition of spasticity * contractures * uncontrolled seizures * focal spasticity

Keywords: bobath; cerebral palsy; neck-trunk stabilization;